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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_______________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: February 20, 1997
_________________
UROMED CORPORATION
_________________________________________________________
(Exact name of registrant as specified in its charter)
Massachusetts 000-23266 04-3104185
_______________________________________________________________________________
(State or Other Jurisdiction (Commission File Number) (I.R.S. Employer
of Incorporation) Identification No.)
64 A Street, Needham, Massachusetts 02194
_________________________________________________________
Address of principal executive offices
Registrant's telephone number, including area code: (617) 433-0033
______________
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ITEM 5. OTHER EVENTS
On February 20, 1997, the Registrant issued a press release reporting its
results for the fiscal quarter and the year ended December 31, 1996.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
EXHIBIT NUMBER DESCRIPTION
99.1 Press Release issued February 20, 1997 reporting the
Registrant's results for the fiscal quarter and year ended
December 31, 1996.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
UROMED CORPORATION
Dated: March 19, 1997 By: /s/Paul J. Murphy
_____________________________
Paul J. Murphy, Treasurer and
Chief Financial Officer
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UROMED
______
C 0 R P 0 R A T I 0 N
64 A Street
Needham, MA 02194
(617) 433-0033 FAX: (617) 433-0032
FOR IMMEDIATE RELEASE
Contact:
Kristen Galfetti or Sally J. Curley
Investor Relations Specialist Senior Consultant
UroMed Corporation Sharon Merrill Associates
Tel: (617) 433-0003 Tel: (617) 542-5300
UROMED CORPORATION ANNOUNCES
FOURTH-QUARTER AND YEAR-END 1996 RESULTS
UroMed Continues Phase I and Prepares for Phase II
Of Its Reliance Insert U.S. Product Launch
NEEDHAM, MA, February 20, 1997--UroMed Corporation (NASDAQ:URMD) today
reported revenues of $0.5 million for the fourth quarter ended December 31,
1996, compared with $0.6 million for the same period of 1995. UroMed reported
a fourth quarter 1996 net loss of $5.5 million, or $0.21 per share, compared
with a net loss of $2.6 million, or $0.12 per share, for the fourth quarter
in 1995. The company ended the fourth quarter with cash, cash equivalents and
short-term investments totaling $101.6 million.
For the year ended December 31, 1996, UroMed reported revenues of $2.6
million, compared with revenues of $1.1 million in 1995. UroMed reported a
net loss of $47.7 million, or $1.87 per share, for 1996, compared with a net
loss of $9.7 million, or $0.46 per share, for 1995. The 1996
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results include a one-time $30.2 million, or $1.18 per share, charge
accounted for as purchased research and development, relating to the
acquisition of the Miniguard Patch, now known as the Impress Miniguard, and
all incontinence technology of the Advanced Surgical Intervention (ASI)
Liquidating Trust.
"We are pleased with UroMed's accomplishments in 1996 from both a
financial and a corporate perspective," said John G. Simon, chairman of the
board and chief executive officer. "Results reported for the year were within
company expectations and demonstrated our ability to continue to control
expenses. As expected, U.S. product sales did not contribute significantly to
revenues this year due to the timing and targeted nature of our
fourth-quarter U.S. launch. In addition to exercising spending controls, in
the fourth quarter we strengthened our cash position by successfully
completing a $69 million convertible debt offering."
UroMed Fourth-quarter 1996 Results/2
Simon continued, "In addition to our financial achievements, UroMed achieved
two initial product milestones in 1996: 1) the receipt of U.S. Food and Drug
Administration PMA approval on the Reliance Insert and 2) the acquisition of the
FDA-cleared Miniguard Patch, now known as the Impress Miniguard. To date, we are
pleased with the first physician training phase of our product roll-out of the
Reliance Insert and have received a welcome initial response from both
physicians and patients. Presently, we have more than 1,000 physicians who have
been trained and who are ready to prescribe the Reliance Insert. This target
group of physicians will provide UroMed with a solid base which will support
initial patient demand. In addition, we continue to prepare for the commercial
launch of the Impress Miniguard, which we expect to occur in late 1997 or early
1998."
Simon concluded, "Together, the Reliance Insert and Impress Miniguard will
enable UroMed to provide women who suffer from stress urinary incontinence with
multiple treatment options and, subsequently, an improved quality of life. Our
success in the areas of finance, regulatory, and sales and marketing further
underscores our strong leadership position in the urological and gynecological
markets. We are hopeful that our aggressive research and development, and
in-licensing and acquisition activities will leverage our existing resources and
add to this leadership position."
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The Reliance Urinary Control Insert is a unique new treatment for urinary
incontinence offering an alternative to adult diapers. A first-of-its-kind
product, the Reliance Insert is a small, self-administered, discreet,
single-use device designed to immediately prevent urine leakage caused by
mild to moderate female stress urinary incontinence, the most common type of
incontinence in women. A complementary product to the Reliance Insert, the
Impress Miniguard is a small, disposable. prescription adhesive patch placed
externally against the urethral opening to help block leakage in women with
mild to moderate stress urinary incontinence.
Urinary incontinence is common among women of all ages. A recent
Contemporary Urology study estimates that while 50 to 75 percent of women in
chronic care facilities have urinary incontinence, 20 percent of women ages 40
to 60 suffer from stress urinary incontinence. Surveys further indicate that
women wait a period of years before discussing the condition with their
physicians due to the limited options historically available to them.
UroMed Fourth-quarter 1996 Results/3
UroMed Corporation was founded to develop, manufacture and market products
for the management of urological and gynecological disorders. The company's
first two products, the Reliance Urinary Control Insert and the Impress
Miniguard, are intended for the management of certain types of female urinary
incontinence. According to company estimates, urinary incontinence (UI), the
loss of bladder control resulting in the involuntary leakage of urine, afflicts
approximately 26 million women in the United States, Japan and selected
countries in Europe. UroMed's Reliance Insert and Impress Miniguard are designed
for an estimated target market in excess of six million of these women worldwide
who suffer from certain types of UI and seek to maintain their active
lifestyles. UroMed has designed the Reliance Insert in order to provide the
appropriate UI patient, who now typically wears diapers or pads, with similar
lifestyle benefits to those conferred by a tampon in the case of menstruation.
UroMed's Impress Miniguard is designed for a broader group of mild to moderate
UI patients.
A copy of the condensed statement of operations and balance sheet of UroMed
Corporation for selected periods indicated are attached.
The company recognizes that the previous paragraphs contain forward-looking
statements relating to the company's future activities,
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including timing related to the commercial launches of the Reliance Insert
and Impress Miniguard, and the company's research and development,
in-licensing and acquisition activities. These forward-looking statements are
based largely on the company's expectations and are subject to a number of
risks and uncertainties beyond the company's control. Actual results could
differ materially from these forward-looking statements as the result of
certain risks, including the uncertainty of manufacturing scale-up and market
acceptance of the Reliance Insert and the Impress Miniguard as well as the
company's dependence on these two products going forward. There can be no
assurance that these risks would not have a material adverse effect on the
company. Other relevant risks are described in the company's Current Report
on Form 8-K, filed January 31, 1997, under the headings "Forward-Looking
Statements and Associated Risks" and "Risk Factors," which are incorporated
herein by reference.
Reliance-Registered Trademark- is a registered trademark of UroMed Corporation.
Impress-TM- Miniguard is a trademark of UroMed Corporation.
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UroMed Fourth-quarter Results/4
UROMED CORPORATION
CONDENSED STATEMENT OF OPERATIONS
(UNAUDITED)
(In Thousands, except per share data)
<TABLE>
<CAPTION>
THREE MONTHS ENDED YEAR ENDED
DECEMBER 31, DECEMBER 31,
-------------------- ---------------------
1995 1996 1995 1996
--------- --------- --------- ----------
<S> <C> <C> <C> <C>
Revenues.................. $ 648 $ 503 $ 1,052 $ 2,622
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Cost and expenses:
Cost of revenues.......... 1,431 1,219 2,564 5,110
Research and development.. 1,378 1,863 6,821 37,597*
Marketing and sales....... 724 2,351 2,169 7,276
General and administrative. 456 950 1,898 2,898
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Total costs and expenses... 3,989 6,383 13,452 52,881
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Loss from operations....... (3,341) (5,880) (12,400) (50,259)
Interest income............ 737 1,289 2,692 3,462
Interest expense........... (1) (862) (4) (863)
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Net loss................... ($ 2,605) ($ 5,453) ($ 9,712) ($ 47,660)
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Net loss per share......... ($ 0.12) ($ 0.21) ($ 0.46) ($ 1.87)*
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Weighted average common
shares outstanding...... 22,432 26,436 21,262 25,544
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</TABLE>
* Includes $30,200,000, or $1.18 per share, spent on the acquisition of the
Impress-TM- Miniguard technology in the second quarter of 1996 and related
expenses.
